impact of osteoporosis and vertebral fractures on quality of life a population based study in valencia spain the fravo study

a population-based study in Valencia, Spain The FRAVO Study José Sanfélix-Genovés1,2*, Isabel Hurtado1, Gabriel Sanfélix-Gimeno1, Begoña Reig-Molla3and Salvador Peiró1 Abstract Backgroun

R E S E A R C H Open Access

Impact of osteoporosis and vertebral fractures on quality-of-life a population-based study in

Valencia, Spain (The FRAVO Study)

José Sanfélix-Genovés1,2*, Isabel Hurtado1, Gabriel Sanfélix-Gimeno1, Begoña Reig-Molla3and Salvador Peiró1

Abstract

Background: To describe the health related quality of life in a population sample of postmenopausal women over the age of 50 and resident in the city of Valencia (Spain), according to the presence/absence of osteoporosis and the severity of prevalent morphometric vertebral fractures

Methods: A cross-sectional age-stratified population-based sample of 804 postmenopausal women of 50 years of age and older were assessed with the SF-12 questionnaire Information about demographic features, lifestyle, clinical features, educational level, anti-osteoporotic and other treatments, comorbidities and risk factors for

osteoporosis were collected using an interviewer-administered questionnaire and densitometric evaluation of spine and hip and spine x-rays were carried out

Results: In the non-adjusted analysis, mild and moderate-severe vertebral fractures were associated with decreased scores in the SF-12 Physical Component Summary (PCS) but not in the Mental Component Summary (MCS), while densitometric osteoporosis with no accompanying fracture was not associated with a worse health related quality

of life In multivariate analysis worse PCS scores were associated to the age groups over 70 (-2.43 for 70-74 group and -2.97 for 75 and older), chronic conditions (-4.66, -6.79 and -11.8 according to the presence of 1, 2 or at least 3 conditions), obesity (-5.35), peripheral fracture antecedents (-3.28), hypoestrogenism antecedents (-2.61) and the presence of vertebral fracture (-2.05)

Conclusions: After adjusting for confounding factors, the physical components of health related quality of life were significantly lower in women with prevalent osteoporotic vertebral fractures than in women -osteoporotic or not- without vertebral fractures

Introduction

Osteoporosis is a common condition characterized by

decreased bone mass and increased susceptibility to

fractures [1] The most common clinical complications

of osteoporosis are hip, wrist, and vertebral fractures

Vertebral fractures (VFX) are the most prevalent

osteo-porosis-related fractures but they are often

asympto-matic, and their underdiagnosis and undertreatment is

well documented [2,3]

Measures of Health Related Quality of Life (HRQoL)

have gained increasing attention as relevant outcomes in

clinical studies of osteoporosis [4,5] These measures are

also used in epidemiological surveys, complementary to data on morbidity and health care utilization, to estimate the burden of disease and often to compare with other chronic diseases Several instruments, both generic and disease targeted, have been used to examine HRQoL in osteoporosis and osteoporotic fractures [5-7] The speci-fic instruments most widely used include the Osteoporo-sis Quality of Life Questionnaire (OQLQ) [6,7] and its reduced version the mini-OQLQ [8], the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) [9,10], the Osteoporosis Assessment Questionnaire (OPAQ) [11,12], the Osteo-porosis-Targeted Quality of Life Questionnaire (OPT-QoL) [13,14] and the assessment of health-related quality

of life in osteoporosis (ECOS-16) [15] Among the generic instruments, those most used in osteoporotic

* Correspondence: sanfelix_jos@gva.es

1 Centro Superior de Investigación en Salud Pública (CSISP), Valencia, Spain

Full list of author information is available at the end of the article

© 2011 Sanfélix-Genovés et al; licensee BioMed Central Ltd This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and

patients includes the EuroQol 5-D (EQ5D) [16,17], the

Medical Outcomes Study Survey Form (MOS-SF) in its

SF-12 [18] or SF-36 [16] versions that could be combined

with the disease-specific module Quality of Life in

Osteo-porosis (QUALIOST) [19,20], and the Health Utility

Index [7,21]

Vertebral fractures and deformities result in back pain,

disability, limitations in physical functioning and

psy-chosocial impairment [22] An increasing amount of

lit-erature has shown the relation between prevalent VFX

(their number, severity and, occasionally, lumbar

locali-zation) and HRQoL decline [5,18,23-26] Lower HRQoL

has also been associated with incident VFX, with or

without clinical manifestations [5,27-29] However, the

association with osteoporosis in the absence of fracture

or with only mild morphometric fractures has been less

studied The aim of this study is to describe the HRQoL

in a population sample of postmenopausal women of 50

years old and over and resident in the city of Valencia

(Spain), according the presence/absence of osteoporosis

and the severity of prevalent morphometric vertebral

fractures

Methods

Design

Population-based cross-sectional study conducted

between February 2006 and March 2007, designed

pri-marily to estimate the prevalence of densitometric

osteoporosis and vertebral fracture

Population and simple

The study’s population was post-menopausal women

over the age of 50 living in the city of Valencia, Spain,

excluding women with cognitive impairment, physical

impediments preventing women from going to the

radi-ology centre by her own means, race other than

Cauca-sian and unwillingness to participate in the study The

methods of the FRAVO study, mainly designed to

esti-mate the population prevalence of vertebral fracture and

densitometric osteoporosis, have been fully described

elsewhere [30] Briefly, 1,758 women were selected from

a simple age-stratified (50-54, 55-59, 60-64, 65-69, 70-74

y 75+) random sample from among the residents of

Valencia, and invited to participate in the study Only

1,314 confirmed receipt of the letter (74.7%) and of

these, 76 presented at least one exclusion criteria, 371

declined to participate and 43 did not keep their

appointments for the examinations, leaving 824 women

participating in the study In 19 cases the spine x-ray or

the densitometry was not available and in 1 case the

HRQoL questionnaire was not entirely fulfilled, leaving

804 women for analysis (dropouts by reason and age

groups are described in Additional file 1)

Main outcome measure

Health related quality of life was measured with the Spanish version-2 of the MOS SF-12 questionnaire [31],

a simplified self-administered version of the SF-36 that could be completed within two minutes The SF-12 is a generic instrument consisting of 12 items covering the domains of physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emo-tional problems and mental health These domains can

be summarized into a physical component summary scale (PCS-12) and a mental component summary scale (MCS-12) In the SF-12 version-2 for each one of the 8 domains and the summary components, items are aggre-gated and transformed into a 0 to 100 score, a low score indicating a lower HRQoL To facilitate interpretation, the PCS and MCS scores are standardized with popula-tion norms, 50 (SD: 10) being the average of the general population [31] Because Spanish weights were not avail-able for the SF-12v2 at the time of analysis, we use the North American weights Figures higher or lower than

50 should be interpreted as better or worse HRQoL scores than the reference population

Other variables and definitions

Information about demographic features, lifestyle, clin-ical features, educational level, anti-osteoporotic and other treatments, comorbidities and risk factors for osteoporosis was collected using an interviewer-administered questionnaire Among other variables, it included the subject’s age, place of birth, educational level (no studies, primary, secondary/university, and unknown studies), obesity grade II or more (body mass index (BMI)>35), hypoestrogenism antecedents (meno-pause before age 40 and/or amenorrhea for more than

a year) and asked whether the subject had a history of osteoporotic fracture excluding major traumatisms in any location Using the information on risk factors, comorbidities and treatments, we constructed a variable

to account for the presence of chronic conditions that could affect the HRQoL: taking corticoids for at least 3 months in the last year, gait abnormalities for any rea-son (or postural instability, impaired balance or anticon-vulsive treatment), cognitive or visual deficit, depression (or taking lithium), and specific self-referred conditions such as gastrectomy, bowel resection, inflammatory bowel disease, thyroidectomy (or taking thyroxin), diabetes mellitus, chronic liver diseases, chronic obstructive pulmonary disease, rheumatoid arthritis, chronic kidney failure and transplantation (or immuno-suppressive treatment)

Spine radiographs were performed using standardized techniques and two radiologists, blinded to all data

concerning the patients, performed the semiquantitative

evaluation of the radiographs using the Genant method

[32] to standardize the diagnosis of fractures Each

ver-tebrae, including T4 to L4, were classified into one of

the five grades on Genant’s score Densitometric

exami-nations were performed with two calibrated

densit-ometers (Dual-energy X-ray absorptiometry or DXA

central) for the lumbar spine and the femoral neck The

World Health Organization definitions [33] of

osteope-nia and of osteoporosis were applied in both locations

and the greater value was taken into account

Ethical Aspects

The study was approved by the Ethics Committee for

Clinical Research of the Primary Care Departments of

Valencia and Castellon (Regional Government of

Valen-cia Department of Health) All of the participating

women were informed of the study’s characteristics and

risks (basically, those associated with exposure to

x-rays), and all gave signed informed consent prior to

examination Because the study data could be clinically

useful, we communicated the results of the

densito-metric and x-ray examinations to the patients, with a

recommendation to visit their primary care doctor when

pertinent

Analysis

First, we describe the socio-demographic and clinical

characteristics of the sample according to the following

4 groups: 1) absence of VFX without densitometric

osteoporosis, 2) absence of VFX with densitometric

osteoporosis, 3) presence of only mild VFX Genant

grade 1, and 4) presence of moderate-severe VFX

Gen-ant grade 2-3 Chi-square (or Fisher exact test when

pertinent) was used to assess differences among groups

Second, we perform a descriptive analysis of the PCS

and MCS scores stratified by groups and characteristics

of the sample To assess the possible differences

between groups Multivariable Analysis of Variance

(MANOVA) was used The relevant p-value in this

ana-lysis (variance between groups) was specified as p

(groups) in the corresponding tables Because it provides

helpful information, p-values corresponding to the

var-iance between levels of the corresponding independent

variable, specified as p(variable name), were also

included in the tables Third, we estimate means and

confidence intervals (95%CI) of the SF12 domains and

the PCS and MCS scores for the 4 groups, and use the

ANOVA Oneway methods to evaluate differences

between groups Totals for SF-12 domains and summary

scores were weighted to represent the population

age-structure of the Valencia city Finally, we use

multivari-ate regression analysis to analyze the independent effects

of VFX and osteoporosis on the PCS scores, controlling

the effect of different covariables (age, chronic condi-tions, obesity, hypoestrogenism antecedents, fracture antecedents and educational level) We constructed an initial model with all relevant variables and we used the backward-stepwise technique, with a removing probabil-ity of 0.10 and an entry probabilprobabil-ity of 0.05, to retain the significant factors All analyses were performed using the STATA 10.0 (Stata Corp., College Station, Texas) statistical software

Results

Clinical and demographic characteristics of the partici-pating women according to the four predefined groups

of absence (with or without densitometric osteoporosis)

or presence of VFX (mild or moderate-severe) in the x-ray are shown in Table 1 Relevant characteristics of the sample included 51.9% of women with densitometric osteopenia and 28.0% with densitometric osteoporosis, 72.9% with at least one chronic condition, 22.1% with antiosteoporotic treatment, and 15.6% (mild: 9.4%; mod-erate-severe: 6.2%) with radiological vertebral fractures (21.4% weighting the sample by the age structure of the city of Valencia) Vertebral fracture was most preva-lent with older age groups, lower educational level, den-sitometric osteoporosis, self-referred antecedents of non-vertebral clinical fracture, and in women with anti-osteoporotic treatment

PCS scores by the women’s characteristics and groups are shown in Table 2 PCS scores decreased with age (from 48.5 in the 50-54 years group to 40.4 in the 75 and older group), number of chronic conditions (from 50.6 for no comorbidities to 36.9 in people with 3 or more chronic conditions), antecedents of non-vertebral fracture, hypoestrogenism antecedents, obesity, antios-teoporotic treatment, and lumbar or both thoracic and lumbar localization, and increased with educational level PCS scores also decreased with the presence of vertebral fracture (mild: 41.6, and moderate-severe: 40.3,

vs 45.6 and 46.2 in the groups without VFX) MCS scores (Table 3) were only affected by chronic condi-tions (worse with more condicondi-tions) and obesity (better

in women with BMI higher than 35)

Women’s scores in the eight SF-12 domains and both summary components (total are weighted by the age structure of the Valencia female population) are shown

in Table 4 Physical functioning (more than 65 in woman without fracture vs 44 in women with moder-ate-severe fracture), physical role, social functioning, general health, emotional role and PCS showed statisti-cally significant differences, usually between the moder-ate-severe VFX group and groups without fracture The densitometric osteoporotic group did not show differ-ences between groups with normal-osteopenia densito-metry The domains of bodily pain, vitality mental

Table 1 Clinical and socio-demographic characteristics of the sample by osteoporosis and morphometric vertebral fracture (%)

Without vertebral fracture With Vertebral fracture Total T-Score

> -2.5

T-Score

Age group (p < 0.001)

Educational level (p < 0.001)

Densitometry (p < 0.001)

Chronic conditions (p = 0.094)*

Antecedents of non-vertebral fracture (p = 0.020)

Hypoestrogenism antecedents (p = 0.407)

Obesity BMI>35 (p = 0.010)

Antiosteoporotic treatment (p < 0.001)

Vertebral fracture localization (p < 0.001)

All percentages by rows except in the total column (by columns) BMI: Body Mass Index *Chronic conditions: corticoid treatment, gait abnormalities for any reason, cognitive or visual deficit, depression, gastrectomy, bowel resection, inflammatory bowel disease, thyroidectomy, diabetes mellitus, chronic liver diseases, chronic obstructive pulmonary disease, rheumatoid arthritis, chronic kidney failure and transplantation p-values correspond to Pearson’s chi-squared test.

Table 2 Physical component summary score by population characteristics

Without vertebral fracture With Vertebral fracture Total T-Score > -2.5 T-Score ≤ -2.5 Mild Mod-severe

Age group [p(model)<0.0001; p(age)<0.0001; p(groups) = 0.0405]

Educational level [p(model)<0.0001; p(educational level)<0.0001; p(groups) = 0.0265]

Densitometry [p(model)<0.0028; p(densitometry)<0.9419; p(groups) = 0.0004]

Chronic conditions** [p(model)<0.0001; p(chronic)<0.0001; p(groups) = 0.0186]

Antecedents of non-vertebral fracture [p(model)<0.0058; p(non-vert fract)<0.0001; p(groups) = 0.0010]

Hypoestrogenism antecedents [p(model)<0.0001; p(hypoestrogenism)<0.0001; p(groups) = 0.0003]

Obesity BMI>35 [p(model)<0.0001; p(obesity)<0.0001; p(groups) = 0.0005]

Antiosteoporotic treatment [p(model)<0.0001; p(treatment)<0.0143; p(groups) = 0.0008]

Vertebral fracture localization [p(model) = 0.0700; p(localization) = 0.0375; p(groups) = 0.7755]

Total [p(groups) = 0.0004]

*Total weighted to represent the distribution of the female population by age in the city of Valencia.

**Chronic conditions: corticoid treatment, gait abnormalities for any reason, cognitive or visual deficit, depression, gastrectomy, bowel resection, inflammatory bowel disease, thyroidectomy, diabetes mellitus, chronic liver diseases, chronic obstructive pulmonary disease, rheumatoid arthritis, chronic kidney failure and transplantation BMI: Body Mass Index.

p-values correspond to the multivariate analysis of variance (MANOVA).

Table 3 Mental component summary score by population characteristics

Without vertebral fracture With Vertebral fracture Total T-Score > -2.5 T-Score ≤ -2.5 Mild Mod-severe

Age group [p(model) = 0.3440; p(age) = 0.6394; p(groups) = 0.1509]

Educational level [p(model) = 0.1164; p(educ) = 0.2030; p(groups) = 0.1340]

Densitometry [p(model) = 0.0561; p(densito) = 0.0753; p(groups) = 0.4137]

Chronic conditions** [p(model)<0.0001; p(chronic)<0.0001; p(groups) = 0.0354]

Antecedents of non-vertebral fracture [p(model) = 0.2081; p(antec) = 0.5708; p(groups) = 0.1379]

Hypoestrogenism antecedents [p(model) = 0.1251; p(hypoes) = 0.2038; p(groups) = 0.1181]

Obesity BMI>35 [p(model) = 0.0303; p(obes) = 0.0242; p(groups) = 0.2067]

Antiosteoporotic treatment [p(model) = 0.2264; p(treatment) = 0.8042; p(groups) = 0.1425]

Vertebral fracture localization [p(model) = 0.7076; p(loc) = 0.5582; p(groups) = 0.3955]

Total [p(groups) = 0.1330]

*Total weighted to represent the distribution of the female population by age in the city of Valencia.

**Chronic conditions: corticoid treatment, gait abnormalities for any reason, cognitive or visual deficit, depression, gastrectomy, bowel resection, inflammatory bowel disease, thyroidectomy, diabetes mellitus, chronic liver diseases, chronic obstructive pulmonary disease, rheumatoid arthritis, chronic kidney failure and transplantation BMI: Body Mass Index.

p values correspond to the multivariate analysis of variance (MANOVA).

health and the MCP score did not show differences

among groups

Results of the multivariable regression fitted to explore

the independent relationship between the PCS score and

VFX controlling the effect of possible confounders are

shown in Table 5 From a constant of 51.83, PCS scores

decrease with age groups older than 70 (-2.43 for 70-74

group and -2.97 for 75 and older), chronic conditions

(-4.66, -6.79 and -11.8 according to the presence of 1, 2

or at least 3 conditions), BMI > 35 (-5.35), peripheral

fracture antecedents (-3.28), and hypoestrogenism

ante-cedents (-2.61) Controlling the effect of these variables,

the presence of VFX (any grade) was independently

associated with a reduction of -2.05 in the PCS score

Discussion

In the bivariate analysis (not adjusted) mild and

moder-ate-severe vertebral fractures were associated with a

decreased HRQoL measured by the SF-12 Physical

Component Summary score but not with the Mental

Component Summary score, while densitometric

osteo-porosis with no accompanying fracture was not

asso-ciated with any deterioration in HRQoL Multivariate

analysis, controlling by several confounders including

age and comorbidities, retained the association between

vertebral fracture and worse physical HRQoL These

results confirm that prevalent morphometric vertebral fractures are independently associated with lower scores

in the physical domains of HRQoL On the contrary, and as expected, densitometric osteoporosis without accompanying fracture was not related with HRQoL physical scores

Table 4 SF-12 domains and summary scores by presence or absence of osteoporosis and morphometric vertebral fracture

Without vertebral fracture With Vertebral fracture Total* T-Score > -2.5 T-Score ≤ -2.5 Mild Mod-severe

p < 0.0001 (62.14-67.96) (60.21-71.04) (49.22-65.25) (34.53-53.47) (57.45-63.48)

p = 0.0003 (78.83-82.74) (74.99-82.14) (65.88-77.54) (62.91-76.08) (75.09-79.10)

p = 0.3741 (70.65-79.04) (70.65-79.04) (63.53-81.4) (61.63-78.36) (71.87-76.47)

p = 0.0146 (47.24-51.24) (45.50-52.77) (34.15-46.11) (39.00-52.99) (45.62-49.51)

p = 0.3147 (19.86-24.45) (18.36-25.97) (20.82-33.77) (11.88-26.11) (19.79-24.10)

p = 0.0003 (81.2-87.5) (78.50-86.07) (71.49-84.42) (66.97-82.02) (79.80-84.17)

p = 0.0250 (84.78-87.95) (79.76-85.56) (78.36-88.08) (73.95-86.04) (82.47-85.91)

p = 0.4418 (55.11-58.70) (51.46-57.75) (53.90-63.19) (52.85-63.64) (55.08-58.66)

p = 0.0004 (44.41-46.23) (44.01-47.43) (39.07-44.17) (37.25-43.25) (43.24-45.05)

p = 0.1330 (44.90-46.41) (42.69-45.32) (44.32-48.25) (43.00-48.08) (44.54-46.06)

SF-12: Medical Outcomes Study Survey Form 12; PCS: Physical Component Summary; MCS: Mental Component Summary *Total weighted to represent the distribution of the female population by age in the city of Valencia.

Table 5 Factors associated with Physical Component Summary score in women of 50 years and older

Coef 95%CI p Age group 70-74 years -2.43 -4.24; -0.62 0.009

75 years and older -2.97 -5.53; -0.41 0.023 Chronic conditions* 1 -4.66 -6.36; -2.95 <0.001

2 -6.79 -8.73; -4.86 <0.001

3 or more -11.48 -13.74; -9.23 <0.001 Obesity (BMI>35) -5.35 -7.57; -3.12 <0.001 Non-vertebral fracture -3.28 -6.32; -0.24 0.034 Hypoestrogenism

antecedents

-2.61 -4.30; -0.92 0.002 Vertebral fracture -2.05 -3.97; -0.14 0.036 Constant 51.83 50.50; 53.15 <0.001

n = 804; p(F)<0.0001; r 2

= 0.224; Adjusted r 2

= 0.215 BMI: Body mass index 95%CI: 95% Confidence Interval *Chronic conditions: corticoid treatment, gait abnormalities for any reason, cognitive or visual deficit, depression, gastrectomy, bowel resection, inflammatory bowel disease, thyroidectomy, diabetes mellitus, chronic liver diseases, chronic obstructive pulmonary disease, rheumatoid arthritis, chronic kidney failure and transplantation.

Regarding the literature on the topic [5,7-10,12,

16,18,20-29,34], the accurate estimation of osteoporosis

and VFX impact on HRQoL is difficult because the

populations studied and the definitions and methods

used are particularly heterogeneous: 1) Previous studies

may have used population samples as in our study, but

also samples from primary care patients -and, therefore

with some health problems- or even samples from

hos-pital outpatient rheumatology clinics with more severe

patients; 2) fracture definitions vary from morphometric

(using different techniques to identify and grade

defor-mities) to patients’ self-referred fractures or limited to

VFX with clinical symptoms; 3) designs vary from

cross-sectional (prevalent fractures) to prospective (incident

fractures) with different temporal distances between the

fracture and the HRQoL instrument administration; 4)

instruments used to measure HRQoL are very different

and with different clinimetric properties, and 5) while

VFX are more prevalent in aged people and a

substan-tial proportion of these individuals may have clinically

relevant co-morbidities and concomitant functional

lim-itations, study analyses do not always take into account

confounders, including comorbidities or osteoporotic

fractures from other localizations (i.e., hip fractures) In

general, this literature suggest that the more severe the

vertebral fractures (clinical, incident, referred by

patients, or with samples from specialized centres with

more severe patients, multiple fractures) the higher the

effect on HRQoL On the contrary, in osteoporotic

patients with no fractures or only mild prevalent mor-phometric fractures, the effect can be minimal Our results are consistent with this interpretation, although mild morphometric fractures (Genant grade 1) seem to affect physical domains in very similar ways to moder-ate-severe fractures

PCS and MCS scores (not always age-adjusted) from studies reporting these summary components from SF-36 or SF-12 surveys [18,23-29,34] are shown in Table 6 In general, the PCS score follows the behaviour described with few differences between women with or without VFX in the case of prevalent fractures in popu-lation studies and higher in selected samples with more severe patients or incident fractures As in our study, MCS scores, with some exceptions, were not different between women with or without VFX

Some of the factors associated with a lower physical HRQoL are similar to those described in other studies (age, chronic conditions, and antecedents of osteoporo-tic fracture) Obesity has also been related to a poorer physical (not mental) HRQoL [35] We have not identi-fied papers adjusting for hypoestrogenism antecedents

in osteoporosis or VFX quality-of-life assessment Although climacteric symptoms may have negative effects on both the physical and mental components of the HRQoL, women with hypoestrogenism antecedents would have more marked climacteric symptoms and could also have other health problems associated with HRQoL losses

Table 6 Physical and Mental Component Summary scores in studies using the Medical Outcomes Study Survey Form

Without VFX

With VFX Without

VFX With VFX FRAVO study Spain Prevalent SF12 45.3; 45.7 41.6; 40.2 45.6; 44.0 46.3; 45.5 Scores for mild and moderate-severe

VFX.

Lai et al, 2010 [34] China Prevalent SF36 14.3 14.1; 12.7 27.8 27.7; 27.2 Scores for morphometric and clinical

VFX.*

Van Schoor et al

2005 [18]

Holland Prevalent SF12 50.0 49.5; 50.8;

42.1

55.8 55.6; 53.6;

55.0

Scores for mild, moderate and severe VFX.

Cockerill et al, 2004

[27]

Europe Prevalent

Incident

SF12 43.7 41.2 (39.9) 49.1 50.8 (47.2) Scores for incident VFX in brackets Hallberg et al, 2004

[28]

Sweden Incident SF36 44.3 29.6 (34.2) 51.3 45.8 (44.3) Scores 2 years after the incident VFX in

brackets.

Falch et al, 2003 [29] Norway Incident SF36 46.2 31.7 46.0 46.2 Referred to hospital for clinical VFX Adachi et al, 2001

[23]

Canada Prevalent SF36 48 44 53 54 Morphometric subclinical VFX Tosteson et al, 2001

[24]

USA Prevalent SF36 47.1 40.1 53.6 54.7 45% with clinical VFX.

Naves Diaz et al,

2001 [25]

Hall et al, 1999 [26] Australia Prevalent SF36 48 36 54 50 Referred to hospital for clinical VFX

PCS: Physical Component Summary Score; MCS: Mental Component Summary Score; SF12: Medical Outcomes Survey Short-Form 12; VFX: Vertebral Fracture.

*PCS and MCS scores seem to use a non standardized range of values.

Apart from contributing to the scarce data in Spain on

HRQoL osteoporosis related, our study has other

strengths First, we use a population sample not

domi-nated by more sick women as in studies using samples

recruited in outpatient clinics or in clinical trials

(typi-cally, people at high risk of fracture) In fact, PCS and

MCS scores of our weighted sample are practically

iden-tical to the SF-12 population values published for Spain

[31] Second, this is one of the larger population

sam-ples with both densitometric and spine x-ray

evalua-tions Third, assessment of VFX was carried out with

standardized and reliable methods Fourth, we used

multivariate analysis with an extended set of covariables

to control confounding

The study also has several limitations First,

cross-sectional design does not allow the establishment of

causal relationships VFX can be a causal factor of

deterioration in physical HRQoL, but limitations in

physical function can also causally contribute to VFX

Second, information on chronic conditions was

self-referred and although we use patient pharmacologic

treatments to improve this data, figures are subject to

the usual biases of data obtained from interviews

Third, our sample (broken up into four non-balanced

groups and analyzed for several stratums of age,

chronic conditions, etc.) has few observations in

cer-tain substratums of some groups (i.e VFX in younger

women) and some of the HRQoL estimations can be

quite unstable Therefore, HRQoL figures in the

stra-tum-groups should be considered with caution,

espe-cially in the extreme stratums with fewer cases

Fourth, our questionnaire had no information about

physical activity, a relevant variable that could have

influence on osteoporosis, fractures and HRQoL Fifth,

our study used the SF12 questionnaire, a generic

HRQoL measurement instrument that allow us to

compare our results with many of the published

stu-dies on osteoporosis and other diseases, however it is

also possible that this instrument was not responsive

enough to detect small changes in HRQoL in

osteo-porotic patients

After adjusting for confounding factors, our results

indicate that HRQoL was significantly lower in women

who have experienced prevalent osteoporotic vertebral

fractures (as compared with women -osteoporotic or

not- without fractures) The most clinically relevant

impact on HRQoL occurred in the physical domains,

with an attributable reduction of about 8%-10% in the

PCS score Although the clinical relevance of vertebral

fracture has been well established for long time, these

results are important for burden-of-disease and

cost-of-illness studies, and also reinforce the need to reduce the

underdiagnosis and undertreatment of these fractures

Additional material

Additional file 1: Dropouts in the FRAVO Study Dropouts by reason and age groups.

List of abbreviations (ECOS-16): Assessment of health-related quality of life in osteoporosis; (BMI): Body mass index; (DXA): Dual-energy X-ray; (EQ5D): EuroQol 5-D; (HRQoL): Health Related Quality of Life; (MOS-SF): Medical Outcomes Study Survey Form; (MCS): Mental component summary scale; (MANOVA): Multivariable Analysis of Variance; (OPAQ): Osteoporosis Assessment Questionnaire; (OQLQ): Osteoporosis Quality of Life Questionnaire; (OPTQoL): Osteoporosis-Targeted Quality of Life Questionnaire; (PCS): Physical component summary scale; (QUALIOST): Quality of Life in Osteoporosis; (QUALEFFO): Quality of Life Questionnaire of the European Foundation for Osteoporosis; (VFX): Vertebral fractures.

Acknowledgements Funded by the General Directorate for Health Organization, Evaluation and Research (Project 0018/2005) and the General Directorate for Public Health

of the Ministry of Health of the Autonomous Government of Valencia, and a non-conditioned research grant from Sanofi-Aventis.

Author details

1 Centro Superior de Investigación en Salud Pública (CSISP), Valencia, Spain.

2 Centro de Salud de Nazaret, Agencia Valenciana de la Salud Valencia, Spain.

3 Centro de Salud de Villamarchante, Agencia Valenciana de la Salud Valencia, Spain.

Authors ’ contributions JSG, SP and GSG carry out the design of the study and contributed with intellectual input in the design of this paper BRM and GSG developed the most part of the fieldwork IH and GSG make the analysis and written the initial drafts All authors contributed to the writing of the manuscript, corrected draft versions and approved the final version of the manuscript.

Conflicts of interests None of the sponsors played any role in the study design, the collection, analysis or interpretation of data, the writing of the manuscript, or in the decision to submit it for publication.

Received: 13 October 2010 Accepted: 6 April 2011 Published: 6 April 2011

References

1 Johnell O, Kanis JA: An estimate of the worldwide prevalence and disability associated with osteoporotic fractures Osteoporos Int 2006, 17(12):1726-33.

2 Majumdar SR, Kim N, Colman I, Chahal AM, Raymond G, Jen H, Siminoski KG, Hanley DA, Rowe BH: Incidental vertebral fractures discovered with chest radiography in the emergency department: prevalence, recognition, and osteoporosis management in a cohort of elderly patients Arch Intern Med 2005, 165(8):905-9.

3 Delmas PD, van de Langerijt L, Watts NB, Eastell R, Genant H, Grauer A, Cahall DL, IMPACT Study Group: Underdiagnosis of vertebral fractures is a worldwide problem: the IMPACT study J Bone Miner Res 2005,

20(4):557-63.

4 Guyatt GH, Adachi JD, Clifton J, Griffith LE, Epstein RS, Juniper EF: Quality of life issues in women with vertebral fractures due to osteoporosis Arthritis Rheum 1993, 36(6):750-6.

5 Lips P, van Schoor NM: Quality of life in patients with osteoporosis Osteoporos Int 2005, 16(5):447-55.

6 Lizán Tudela L, Badia Llach X: Quality of life evaluation for osteoporosis [In Spanish] Aten Primaria 2003, 31(2):126-33.

7 Peasgood T, Herrmann K, Kanis JA, Brazier JE: An updated systematic review of Health State Utility Values for osteoporosis related conditions Osteoporos Int 2009, 20(6):853-68.

8 Cook DJ, Guyatt GH, Adachi JD, Epstein RS, Juniper EF, Austin PA, Clifton J,

Rosen CJ, Kessenich CR, Stock JL, Overdorf J, Miller PD, Erickson AL,

McCLung MR, McClung BL, Griffith LE, Ioannidis G: Development and

validation of the mini-osteoporosis quality of life questionnaire (OQLQ)

in osteoporotic women with back pain due to vertebral fractures.

Osteoporosis Quality of Life Study Group Osteoporos Int 1999,

10(3):207-13.

9 Badia X, Díez-Pérez A, Alvarez-Sanz C, Díaz-López B, Diaz-Curiel M, Guillén F,

González-Macias J, Spanish GRECO Study Group: Measuring quality of life

in women with vertebral fractures due to osteoporosis: a comparison of

the OQLQ and QUALEFFO Qual Life Res 2001, 10(4):307-17.

10 Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA,

Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J,

Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I: Quality of life

in patients with vertebral fractures: validation of the Quality of Life

Questionnaire of the European Foundation for Osteoporosis

(QUALEFFO) Working Party for Quality of Life of the European

Foundation for Osteoporosis Osteoporos Int 10(2):150-60.

11 Randell AG, Bhalerao N, Nguyen TV, Sambrook PN, Eisman JA, Silverman SL:

Quality of life in osteoporosis: reliability, consistency, and validity of the

Osteoporosis Assessment Questionnaire J Rheumatol 1998, 25(6):1171-9.

12 Cantarelli FB, Szejnfeld VL, Oliveira LM, Ciconelli RM, Ferraz MB: Quality of

life in patients with osteoporosis fractures: cultural adaptation, reliability

and validity of the Osteoporosis Assessment Questionnaire Clin Exp

Rheumatol 1999, 17(5):547-51.

13 Lydick E, Zimmerman SI, Yawn B, Love B, Kleerekoper M, Ross P, Martin A,

Holmes R: Development and validation of a discriminative quality of life

questionnaire for osteoporosis (the OPTQoL) J Bone Miner Res 1997,

12(3):456-63.

14 Chandler JM, Martin AR, Girman C, Ross PD, Love-McClung B, Lydick E,

Yawn BP: Reliability of an Osteoporosis-Targeted Quality of Life Survey

Instrument for use in the community: OPTQoL Osteoporos Int 1998,

8(2):127-35.

15 Badia X, Prieto L, Roset M, Díez-Pérez A: Development of the ECOS-16

clinical questionnaire for the assessment of the quality of life in patients

with osteoporosis [In Spanish] Med Clin (Barc) 2000, 114(Suppl 3):68-75.

16 Adachi JD, Adami S, Gehlbach S, Anderson FA, Boonen S, Chapurlat RD,

Compston JE, Cooper C, Delmas P, Díez-Pérez A, Greenspan SL, Hooven FH,

LaCroix AZ, Lindsay R, Netelenbos JC, Wu O, Pfeilschifter J, Roux C, Saag KG,

Sambrook PN, Silverman S, Siris ES, Nika G, Watts NB, GLOW Investigators:

Impact of Prevalent Fractures on Quality of Life: Baseline Results From

the Global Longitudinal Study of Osteoporosis in Women Mayo Clin Proc

2010, 85(9):806-13.

17 van Schoor NM, Yu H, Bobula J, Lips P: Cross-geographic region

differences in quality of life in women with and without vertebral

fracture Osteoporos Int 2009, 20(10):1759-66.

18 van Schoor NM, Smit JH, Twisk JW, Lips P: Impact of vertebral deformities,

osteoarthritis, and other chronic diseases on quality of life: a

population-based study Osteoporos Int 2005, 16(7):749-56.

19 Marquis P, Cialdella P, De la Loge C: Development and validation of a

specific quality of life module in post-menopausal women with

osteoporosis: the QUALIOST Qual Life Res 2001, 10(6):555-66.

20 de la Loge C, Sullivan K, Pinkney R, Marquis P, Roux C, Meunier PJ:

Cross-cultural validation and analysis of responsiveness of the QUALIOST:

QUAlity of Life questionnaire In OSTeoporosis Health Qual Life Outcomes

2005, 3:69.

21 Adachi JD, Ioannidis G, Pickard L, Berger C, Prior JC, Joseph L, Hanley DA,

Olszynski WP, Murray TM, Anastassiades T, Hopman W, Brown JP, Kirkland S,

Joyce C, Papaioannou A, Poliquin S, Tenenhouse A, Papadimitropoulos EA:

The association between osteoporotic fractures and health-related

quality of life as measured by the Health Utilities Index in the Canadian

Multicentre Osteoporosis Study (CaMos) Osteoporos Int 2003,

14(11):895-904.

22 Gold DT: The clinical impact of vertebral fractures: quality of life in

women with osteoporosis Bone 1996, 18(3 Suppl):185S-189S.

23 Adachi JD, Ioannidis G, Berger C, Joseph L, Papaioannou A, Pickard L,

Papadimitropoulos EA, Hopman W, Poliquin S, Prior JC, Hanley DA,

Olszynski WP, Anastassiades T, Brown JP, Murray T, Jackson SA,

Tenenhouse A, Canadian Multicentre Osteoporosis Study (CaMos) Research

Group: The influence of osteoporotic fractures on health-related quality

of life in community-dwelling men and women across Canada Osteoporos Int 2001, 12(11):903-8.

24 Tosteson AN, Gabriel SE, Grove MR, Moncur MM, Kneeland TS, Melton LJ: Impact of hip and vertebral fractures on quality-adjusted life years Osteoporos Int 2001, 12(12):1042-9.

25 Naves Díaz M, Díaz López JB, Rodríguez Rebollar A, Gómez Alonso C, Díaz Corte C, Cannata Andía J: Effect of vertebral fracture on health related quality of life in a Spanish population older than 54 years [in Spanish] Med Clin (Barc) 2001, 116(14):533-5.

26 Hall SE, Criddle RA, Comito TL, Prince RL: A case-control study of quality

of life and functional impairment in women with long-standing vertebral osteoporotic fracture Osteoporos Int 1999, 9(6):508-15.

27 Cockerill W, Lunt M, Silman AJ, Cooper C, Lips P, Bhalla AK, Cannata JB, Eastell R, Felsenberg D, Gennari C, Johnell O, Kanis JA, Kiss C, Masaryk P, Naves M, Poor G, Raspe H, Reid DM, Reeve J, Stepan J, Todd C, Woolf AD,

O ’Neill TW: Health-related quality of life and radiographic vertebral fracture Osteoporos Int 2004, 15(2):113-9.

28 Hallberg I, Bachrach-Lindström M, Hammerby S, Toss G, Ek AC: Health-related quality of life after vertebral or hip fracture: a seven-year

follow-up study BMC Musculoskelet Disord 2009, 10:135.

29 Falch JA, Bentzen H, Dahl AA: Pain, functional level and emotional problems of women with osteoporosis and vertebral fractures [in Norwegian] Tidsskr Nor Laegeforen 2003, 123(23):3355-7.

30 Sanfélix-Genovés J, Reig-Molla B, Sanfélix-Gimeno G, Peiró S, Graells-Ferrer M, Vega-Martínez M, Giner V: The population-based prevalence of osteoporotic vertebral fracture and densitometric osteoporosis in postmenopausal women over 50 in Valencia, Spain (the FRAVO Study) Bone 2010, 47(3):610-6.

31 Vilagut G, Valderas JM, Ferrer M, Garin O, López-García E, Alonso J: Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components [in Spanish] Med Clin (Barc) 2008, 130(19):726-35.

32 Genant HK, Wu CY, van Kuijk C, Nevitt MC: Vertebral fracture assessment using a semiquantitative technique J Bone Miner Res 1993, 8:1137-48.

33 Naves M, Díaz-López JB, Gómez C, Rebollar A, Rodríguez-García M, Cannata-Andía JB: The effect of vertebral fracture as a risk factor for osteoporotic fracture and mortality in a Spanish population Osteoporos Int 2003, 14:520-4.

34 Lai BM, Tsang SW, Lam CL, Kung AW: Validation of the quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-31) in Chinese Clin Rheumatol 2010, 29(9):965-72.

35 Hopman WM, Berger C, Joseph L, Barr SI, Gao Y, Prior JC, Poliquin S, Towheed T, Anastassiades T, CaMos Research Group: The association between body mass index and health-related quality of life: data from CaMos, a stratified population study Qual Life Res 2007, 16(10):1595-603.

doi:10.1186/1477-7525-9-20 Cite this article as: Sanfélix-Genovés et al.: Impact of osteoporosis and vertebral fractures on quality-of-life a population-based study in Valencia, Spain (The FRAVO Study) Health and Quality of Life Outcomes

2011 9:20.

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